September 13, 2019. This is the first treatment for peanut allergies and if this drug is approved despite the unanswered questions, it will set a precedent for future drugs to treat food allergies. It is especially important that new classes of products provide strong evidence of safety and efficacy before approval, because it will be difficult if not impossible to obtain it afterwards.
Read More »On Medical Treatments & Products
NCHR Comment on FDA’s Draft Guidance to Industry on Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy
September 10, 2019: In response to FDA’s request for public comments, we stated that the agency should require better testing of hormonal birth control pills and patches. Current studies don’t include enough women with higher BMIs or track blood clot risks properly. Our comments push for stronger safety standards that test hormonal contraceptives on women of all weights, especially since some birth control methods may be less effective or more dangerous for larger women.
Read More »NCHR Comment on USPSTF Draft Recommendation on Illicit Drugs Use Screening
September 9, 2019. We strongly encourage the USPSTF to delay recommendations until they obtain evidence to ensure that screening for illicit drug use does not have unintended consequences that outweigh any benefits.
Read More »NCHR Testimony on Descovy for PrEP
August 7, 2019. We understand the desire to provide a new PrEP treatment indicated for a broad population, especially when that new treatment is expected to potentially have fewer risks for kidneys and bone density. However, it is inappropriate and potentially dangerous to approve this drug for subgroups of patients that haven’t been adequately studied. The FDA law requires substantial evidence that the benefits outweigh the risks for each subpopulation that the new indication would include.
Read More »NCHR Testimony on Nintedanib for SSc-ILD
July 25, 2019. There is a critical need for new treatments for SSc-ILD. We all hope that Nintedanib [brand name OFEV] will help slow the rate of decline, but the data are not yet sufficient.
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